About

Chemical Regulatory Services Limited (CRS), who holds and run REACHLINKED.com, was formed by a group of senior executives with lots of experience in the chemical industry, in collaboration with a team of REACH specialists. As an independent representative with no direct involvement in the production or trading of chemicals, CRS can act on your behalf without bias. This can be extremely important, especially if you have multiple agents, indirect exports, or want to alter your supply chain into Europe, either now or in the future.

Originally founded to help Non-EU manufacturers to comply with the REACH legislation as Only Representative, the company meanwhile supports EU Producers and Importers as consultant and/or as Third Party Representative and Downstream Users as consultant in all REACH matters. Unlike most advisors, we offer the complete scope of REACH – related services.

We also provide support within the implementation of the CLP Regulation.

Through our support, your company will reach advice and efficient implementation of Regulations in the chemical industry.

REACH

Introduction

The regulation is based on the principle that it is for manufacturers, importers and downstream users to ensure that they manufacture, place on the market or use such substances that do not adversely affect human health or the environment.

Our current chemical system consists of more than 103,800 chemical substances. Round about 100,000 of these were introduced to the market before 1981 and are listed as “existing chemicals” or “phase-in substances” in EINECS (European Inventory of Existing Commercial Chemical Substances). The rest – more than 3,800 substances – are listed as “new chemicals” in ELINCS (European List of Notified Chemical Substances). For the existing chemicals, which cover more than 97% of the market, there is a lack of information regarding their safety for human health and the environment.

With REACH, this gap is closed. It is the new chemical regulation of the European Parliament and the Council of the European Union, concerning the Registration, Evaluation,Authorisation and Restriction of Chemicals.

The regulation is based on the principle that it is for manufacturers, importers and downstream users to ensure that they manufacture, place on the market or use such substances that do not adversely affect human health or the environment.

In detail, REACH will:

  • improve the protection of human health and the environment,
  • ensure transparency throughout the whole chemical supply chain,
  • transfer responsibility from public authorities to the whole chemical industry (manufacturers, importers and downstream users),
  • create a harmonised system for EINECS and ELINCS,
  • substitute hazardous substances,
  • promote non-animal testing.

Why you are affected by REACH

If you are

  • a manufacturer: any natural or legal person established within the Community who manufactures a substance within the Community, and/or
  • an importer: any natural or legal person established within the Community who is responsible for import, and/or
  • a downstream user: any natural or legal person established within the Community, other than the manufacturer or the importer, who uses a substance, either on its own or in a mixture, in the course of his industrial or professional activities. A distributor or a consumer is not a downstream user. A re-importer exempted pursuant to Article 2(7)(c) shall be regarded as a downstream user,

then REACH affects you. If you fail to register, the consequences are serious. To summarise Article 5: “No data, no market”.

Any manufacturer or importer of a substance, on its own or in mixtures, in quantities of one ton or more per year has to submit a registration to the Agency. Any manufacturer or importer of polymers has to register the monomer substances. In cases where substances/mixtures/monomers are produced or imported in quantities of ten tons or moreper year, the manufacturers or importers have to conduct a chemical safety assessment (CSA) and to create a chemical safety report (CSR). If manufacturers/importers are producing/importing hazardous substances/mixtures, the manufacturers/importers additionally have to create an exposure scenario (ES). To ensure the safe use of chemical substances/mixtures, downstream users are obliged to inform the producer/importer about the application and working conditions, so that the manufacturer/importer can create an individual chemical safety report or respective risk management measures.

As a non-Community manufacturer you cannot register your substances (on their own, in mixtures or in articles) directly. You need a legal entity within the European Community or have to appoint a natural or legal person as your “only representative” (Article 8) to fulfil your obligations. The advantage of an “only representative” is the higher protection of sensitive information and thus better control of your know-how. In addition you can profit from an anonymous appearance in SIEF and consortia. As an EU manufacturer or EU importer you can also appoint a fully responsible “third-party representative” to comply with your obligations under REACH.

Glossary

Definitions according to the REACH-Regulation, Article 3:

actors in the supply chain:
all manufacturers and/or importers and/or downstream users in a supply chain.
agency:
the European Chemical Agency as established by this Regulation.
alloy:
a metallic material, homogenous on a macroscopic scale, consisting of two or more elements so combined that they cannot be readily separated by mechanical means.
article:
an object which during the production is given a special shape, surface, or design which determines its function to a greater degree than does its chemical composition.
competent authority:
the authority or authorities or bodies established by the Member States to carry out the obligations arising from this Regulation.
distributor:
any natural or legal person established within the Community, including a retailer, who only stores and places on the market a substance, on its own or in a mixture, for third parties.
downstream user:
any natural or legal person established within the Community, other than the manufacturer or the importer, who uses a substance, either on its own or in a preparartion, in the course of his industrial or professional activities. A distributor or a consumer is not a downstream user. A re-importer exempted pursuant to Article 2 shall be regarded as a downstream user.
exposure scenario:
the set of conditions, including operational conditions and risk management measures, that describe how the substance is manufactured or used during its life-cycle and how the manufacturer or importer controls, or recommends downstream users to control, exposures of humans and environment. These exposure scenarios may cover one specific process or use or several processes uses as appropriate.
full study report:
a complete and comprehensive description of the activity performed to generate the information. This covers the complete scientific paper as published in the literature describing the study performed or the full report prepared by the test house describing the study performed.
identified use:
a use of a substance on its own or in a mixture, or a use of a preparation, that is intended by an actor in the supply chain, including his own use, or that is made known to him in writing by an immediate downstream user.
import:
the physical introduction into the customs territory of the Community.
importer:
any natural or legal person established within the Community who is responsible for import.
intermediate:
a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance (hereinafter referred to as synthesis):

  1. Non-isolated intermediate: an intermediate that during synthesis is not intentionally removed (except for sampling) from the equipment in which the synthesis takes place. Such equipment includes the reaction vessel, its ancillary equipment, and any equipment through which the substance(s) pass(es) during the a continuous flow or batch process as well as the pipework for the transfer from one vessel to another for the purpose of the next reaction step, but it excludes tanks or other vessels in which the substance(s) are stored after the manufacture.
  2. On-site isolated intermediate: an intermediate not meeting the criteria of a non-isolated intermediate and where the manufacture of the intermediate and the synthesis of (an)other substances(s) from that intermediate take place on the same site, operated by one or more legal entities.
  3. Transported isolated-intermediate: an intermediate not meeting the criteria of a non-isolated intermediate and transported between or supplied to other sites.
manufacturer:
any natural or legal person established within the Community who manufactures a substance within the Community.
manufacturing:
production or extraction of substances in the natural state.
monomer:
a substance which is capable of forming covalent bonds with a sequence of additional like or unlike molecules under the conditions of the relevant polymer-forming reaction used for the particular process.
not chemically modified substance:
a substance whose chemical structure remains unchanged, even if it has undergone a chemical process or treatment, or a physical mineralogical transformation, for instance to remove impurities.
notified substance:
a substance for which a notification has been submitted and which could be placed on the market in accordance with Directive 67/548/EEC.
per year:
per calendar year, unless stated otherwise, for phase-in substances that have been imported or manufactured for at least three consecutive years, quantities per years shall be calculated on the basis of the average production or import volumes for the three preceding calendar years.
phase-in substances:
a substance which meats at least one of the following criteria:

  1. it is listed in the European Inventory of Existing Commercial Chemical Substances (EINECS).
  2. It was manufactured in the Community, or in the countries acceding to the European Union on 1 January 1995 or on 1 May 2004, but not placed on the market by the manufacturer or importer, at least once in the 15 years before the entry into force of this Regulation, provided the manufacturer or importer has documentary evidence of this.
  3. It was placed on the market in the Community, or in the countries acceding to the European Union on 1 January 1995 or on 1 May 2004, before entry into force of this Regulation by the manufacturer or importer and was considered as having been notified in accordance with the first indent of Article 8 (1) of Directive 67/548/ECC but does not meet the definition of a polymer as set out in this Regulation, provided the manufacturer or importer has documentary evidence of this.
placing on the market:
supplying or making available, whether in return for payment or free of charge, to a third party. Import shall be deemed to be placing on the market.
polymer:
means a substance consisting of molecules characterised by the sequence of one or more types of monomer units. Such molecules must be distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units. A polymer comprises the following:

    1. a simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or rather reactant
    2. less than a simple weight majority of molecules of the same molecular weight.
In the context of this definition a “monomer unit” means the reacted form of a monomer substance in a polymer.
Mixture:
a mixture or solution composed of two or more substances.
producer of an article:
any natural or legal person who makes or assembles an article within the Community.
product and process orientated research and development:
any scientific development related to product development or the further development of a substance, on its own, in preparations or in articles in the course of which pilot plant or production trials are used to develop the production process and / or to test the fields of application of the substance.
recipient of a substance or a mixture:
a downstream user or a distributor being supplied with a substance or a mixture.
recipient of an article:
an industrial or professional user, or a distributor, being supplied with an article, but does not include consumers.
registrant:
the manufacturer or the importer of a substance or the producer or importer of an article submitting a registration for a substance.
registrant´s own use:
an industrial or professional use by the registrant.
restriction:
any condition for or prohibiting of the manufacture, use or placing on the market.
robust study summary:
a detailed summary of the objectives, methods, results and conclusions of full study report providing sufficient information to make an independent assessment of the study minimising the need to consult the full study report.
scientific research and development:
any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume less than one tonne per year.
site:
a single location, in which, if there is more than one manufacturer of (a) substance(s), certain infrastructure and facilities are shared.
SME:
small and medium-sized enterprises as defined in the Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprise.
study summary:
a summary of the objectives, methods, results and conclusions of a full study report providing sufficient information to make an assessment of the relevance of the study.
supplier of a substance or a mixture:
any manufacturer, importer, downstream user or distributor placing on the market a substance, on its own or in a mixture, or a mixture.
supplier of an article:
any producer or importer of an article, distributor or other actor in the supply chain placing an article on the market.
substance:
a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.
substances which occur in nature:
a naturally occurring substance as such, unprocessed or processed only by manual, mechanical or gravitational means, by dissolution in water, by flotation, by extraction with water, by steam distillation or by heating solely to remote water, or which is extracted from air by any means.
use and exposure category:
an exposure scenario covering a wide range of processes or uses, where the processes or uses are communicated, as minimum, in terms of the brief general description use.
use:
any processing, formulations, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilisation. 

CLP

Introduction

The CLP Regulation, concerning the Classification, Labelling and Packaging of substances and mixtures, entered into force on 20 January 2009. It concerns to the implementation in the EU of the rules established in the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS). It replaces Directive 67/548/EEC (Dangerous Substances Directive) and Directive 1999/45/EC (Dangerous Preparations Directive).

This Regulation, not less complex than REACh, will ensure a high level of protection of the human health and the environment as well as the free movement of substances and mixtures due to the use of a recognized worldwide classification and labelling system based on the GHS.

CLP will have significant impact on Manufacturers (M), Importers (I) and Downstream Users (DU) that will need to classify and label their substances, mixtures and also certain articles, according to the rules of this new Regulation. Companies will have a big challenge also with SDS authoring and IT systems, training and, if necessary, testing physicochemical properties. It’s important not to forget that GHS will be updated every two years and CLP will need to reflect the changes imposed by the UN.

In detail, CLP will:

  • improve the protection of human health and the environment
  • create an harmonized criteria for the classification of substances and mixtures as well as rules regarding labelling and packaging for hazardous substances and mixtures
  • establish a list of substances with harmonized classifications and labelling (Annex VI)
  • create a classification and labelling inventory of substances notified by M/I
  • substitute the Dangerous Substances and Preparations Directives
  • improve worldwide market access for the EU companies

Why you are affected by CLP

If you are

  • a manufacturer: any natural or legal person established within the Community who manufactures a substance within the Community, and/or
  • an importer: any natural or legal person established within the Community who is responsible for import, and/or
  • a downstream user (including formulator/re-importer): any natural or legal person established within the Community, other than the manufacturer or the importer, who uses a substance, either on its own or in a mixture, in the course of his industrial or professional activities. A distributor or a consumer is not a downstream user. A re-importer exempted pursuant to Article 2(7)(c) of Regulation (EC) No 1907/2006; and/or
  • a distributor (including retailer): any natural or legal person established within the Community, including a retailer, who only stores and places on the market a substance, on its own or in a mixture, for third parties
  • a producer of articles: any natural or legal person who makes or assembles an article within the Community,

then REACh affects you.

Unlike REACh, CLP applies to substances independently of the yearly tonnage band. Some substances like Biocides which are exempt from the REACh regulation, are now under the scope of CLP. Also the Research and Development of chemicals may have obligations within CLP regarding classification, labelling, packaging and notification. The update of Safety Data Sheets (SDS) with the CLP Classification and Labelling is also a very important obligation for Manufacturers and Importers. Besides the label, SDS are the most important hazard communication document.

In summary, the main obligations under CLP are:

  • classification, labelling and packaging of substances and mixtures according to the CLP before placing them on the market
  • classification of substances not placed on the market but that are subject to registration or notification
  • notification of the classification and labelling elements to the classification and labelling inventory established at the Agency (ECHA) in case of placing substances on the market
  • updating the label following any change to the classification and labelling of that substance or mixture, in certain cases without undue delay
  • submitting a proposal to the Competent Authority in one of the Member States in which the substance is placed on the market in case of new information which may lead to a change of the harmonised classification and labelling elements of a substance
  • keeping available all the information required for the purposes of classification and labelling under CLP for a period of at least 10 years after the last supply of a substance or mixture (this information should be kept together with the information required in Article 36 of REACH)
  • taking all reasonable steps available to be aware of new scientific or technical information that may affect the classification of the substances or mixtures placed on the market and when becoming aware of such information considered to be adequate and reliable, a new evaluation of the relevant classification should be done without undue delay
  • classification, labelling and packaging explosive articles according to the CLP before placing them on the market, apart from the obligation to notify the Agency
  • classification of substances not placed on the market that are subject to registration or notification in case of produced or imported articles.

Glossary

Definitions according to the CLP-Regulation, Article 2:

Hazard class:
means the nature of the physical, health or environmental hazard.
Hazard category:
means the division of criteria within each hazard class, specifying hazard severity.
Hazard pictogram:
means the division of criteria within each hazard class, specifying hazard severity.
Signal word:
means a word that indicates the relative level of severity of hazards to alert the reader to a potential hazard; the following two levels are distinguished:

  1. “Danger” means a signal word indicating the more severe hazard categories;
  2. “Warning”means a signal word indicating the less severe hazard categories.
Hazard statement:
means a phrase assigned to a hazard class and category that describes the nature of the hazards of a hazardous substance or mixture, including, where appropriate, the degree of hazard.
Precautionary statement:
means a phrase that describes recommended measure(s) to minimise or prevent adverse effects resulting from exposure to a hazardous substance or mixture due to its use or disposal.
Substance:
means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.
Mixture:
means a mixture or solution composed of two or more substances.
Article:
means an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition.
Producer of an article:
means any natural or legal person who makes or assembles an article within the Community.
Manufacturing:
means production or extraction of substances in the natural state.
Manufacturer:
means any natural or legal person established within the Community who manufactures a substance within the Community.
Import:
means the physical introduction into the customs territory of the Community.
Importer:
means any natural or legal person established within the Community who is responsible for import.
Placing on the market:
means supplying or making available, whether in return for payment or free of charge, to a third party. Import shall be deemed to be placing on the market.
Downstream user:
means any natural or legal person established within the Community, other than the manufacturer or the importer, who uses a substance, either on its own or in a mixture, in the course of his industrial or professional activities. A distributor or a consumer is not a downstream user. A re-importer exempted pursuant to Article 2(7)(c) of Regulation (EC) No 1907/2006 shall be regarded as a downstream user.
Distributor:
means any natural or legal person established within the Community, including a retailer, who only stores and places on the market a substance, on its own or in a mixture, for third parties.
The Agency:
means the European Chemicals Agency established by Regulation (EC) No 1907/2006.
Competent authority:
means the authority or authorities or bodies established by the Member States to carry out the obligations arising from this Regulation.
UN RTDG:
means the United Nations Recommendations on the Transport of Dangerous Goods.
Cut-off value:
means a threshold of any classified impurity, additive or individual constituent in a substance or in a mixture, above which threshold these shall be taken into account for determining if the substance or the mixture, respectively, shall be classified.
Concentration limit:
means a threshold of any classified impurity, additive or individual constituent in a substance or in a mixture that may trigger classification of the substance or the mixture, respectively.
Differentiation:
means distinction within hazard classes depending on the route of exposure or the nature of the effects.
M-factor:
means a multiplying factor. It is applied to the concentration of a substance classified as hazardous to the aquatic environment acute category 1 or chronic category 1, and is used to derive by the summation method the classification of a mixture in which the substance is present.
Package:
means the complete product of the packing operation, consisting of the packaging and its contents.
Packaging:
means one or more receptacles and any other components or materials necessary for the receptacles to perform their containment and other safety functions.
Intermediate packaging:
means packaging placed between inner packaging, or articles, and outer packaging.

Services

Our Services

Once you select CRS as your consulting firm, we will be pleased to provide a comprehensive range of services customized exactly for your needs:

  • Identification of obligations under the REACH-Regulation
  • Implementation of strategy for REACH-Compliance
  • Only Representative (Art. 8 of the REACH-Regulation)
  • Third Party Representative (Art. 4 of the REACH-Regulation)
  • Late pre-registration
  • SIEF communication management
  • Import Certificates for REACH Compliance
  • Creation and submission of IUCLID 5 dossiers (Registration, Inquiry) to the ECHA in REACH-IT
  • Strategy development for the registration
  • REACH and IUCLID 5 Workshops
  • REACH Due Diligence
  • Data Gap analysis
  • Customized Training
  • Project Management
  • Data vendor management (Letter of Access – LoA – purchase)
  • Audits of suppliers concerning REACH Compliance
  • Audits / REACH compliance verification (preparation for Inspections from the Authorities)
  • Creation and review of REACH-compliant SDS
  • CLP notifications / CLP-group notifications
  • Outsourcing of REACH Services.
  • Identification of obligations under the CLP Regulation
  • Implementation of strategy for CLP compliance
  • CLP Due Diligence
  • Customized Training (adapted to your company’s needs)
  • Project management
  • Classification and Re-classification of substances and mixtures in accordance with the CLP Regulation
  • Safety Data Sheets (SDS) authoring and review
  • CLP notifications dossiers / CLP-group notifications dossiers
  • Outsourcing

Contact

CHEMICAL REGULATORY SERVICES LIMITED

Add: 27 Old Gloucester Street, London WC1N 3AX, United Kingdom
Email: [email protected]